Partnership in prostate cancer care
| ISRCTN | ISRCTN31380482 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31380482 |
| Secondary identifying numbers | 32774 |
- Submission date
- 19/12/2016
- Registration date
- 09/01/2017
- Last edited
- 10/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Contact information
Dr Veronica Nanton
Scientific
Scientific
Warwick Medical School
University of Warwick
Coventry
CV4 7AL
United Kingdom
Study information
| Study design | Non-randomised; Interventional; Design type: Process of Care, Education or Self-Management, Complex Intervention, Management of Care |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | ISRCTN31380482_PIS_23Aug16_V1.3.docx |
| Scientific title | Partnership in Prostate Cancer Care: the feasibility of an integrated system to improve patient outcomes and experience (the ICARE-P Study) |
| Study acronym | ICARE-P |
| Study hypothesis | The aim of this study is to assess the feasibility of carrying out a future trial to compare a new model of integrated care for prostate cancer patients with standard care. |
| Ethics approval(s) | Yorkshire and the Humber – South Yorkshire NRES, 04/08/2016, ref: 206153 |
| Condition | Specialty: Primary Care, Primary sub-specialty: Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasms of urinary tract |
| Intervention | Intervention group: Intervention practices are recruited on the basis of their being willing to send practice nurses for Macmillan Cancer follow up training and the additional prostate specific training delivered by members of the project team. Patients will be invited to complete the CHAT-P holistic needs assessment online either alone, with family, friends, peer supporter, or a member of the research team, as is their preference. Links are provided within CHAT-P to sources of advice and information depending on the needs identified. Following completion of the first of 3 HNAs the patient will be directed to make an appointment with the Practice Nurse to discuss any issues of concern identified and personalise the automated Care Plan. The nurse will discuss current concerns which may be physical issues arising from prostate cancer treatment, emotional or social issues, or concerns related to aspects of care. The nurse will discuss aspects of lifestyle and self-management with the patient and where relevant help patients set realistic goals. Where indicated, the nurse will advise the patient regarding further sources of support and advice on specific issues. The nurse will highlight matters of clinical concern to the secondary care team or the GP as necessary. The HNA will be recompleted at intervals specified in our study timeline. All intervention group participants will complete the HNA at least three times during the 8/9-month study period, and hence may have at least three planned follow-up appointments with the Practice Nurse. Control group: Control practices include any practices within the same CCG who would agree to recruit men with prostate cancer to complete the outcome measures. Participating patients will receive usual care for the duration of the study and will complete study outcome measures at baseline and at 8/9 months. |
| Intervention type | Other |
| Primary outcome measure | Feasibility is assessed through recording the the percentage of eligible men recruited and the percentage of men who complete the Holistic Needs assessments at baseline, 6 and 9 months |
| Secondary outcome measures | 1. Cancer survivors' supportive care needs will be assessed using the cancer survivors unmet needs survey (CASUN) at baseline, 6 and 9 months 2. Quality of life will be measured using the EORTC QLQ-C30 at baseline and 9 months 3. Quality adjusted life years will be measured using the EQ-5D-5L at baseline and 9 months 4. Mental wellbeing will be measured using the Warwick and Edinburgh Mental Well-being scale (WEMWBS) at baseline and 9 months 5. Prostate specific concerns will be measured using EPIC at baseline and 9 months 6. Participant engagement in their healthcare will be measured using the Patient Activation measure (PAM) at baseline 3 and 9 months |
| Overall study start date | 01/09/2015 |
| Overall study end date | 30/11/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | Planned Sample Size: 200; UK Sample Size: 200 |
| Participant inclusion criteria | 1. Confirmed diagnosis of prostate cancer and are at any stage of the care pathway 2. Under any treatment regime 3. Diagnosed and/or treated at University Hospitals Birmingham (UHB) or are currently undergoing treatment at UHB 4. Able to read written and comprehend spoken English and complete outcome measures 5. Judged by their GP to have the capacity to participate 6. Aged 18 years or over 7. Able and willing to give informed consent |
| Participant exclusion criteria | 1. Aged under 18 years 2. Unable to give informed consent or complete outcome measures 3. Living in a care setting, suffering from severe mental health problems or unable to communicate in English |
| Recruitment start date | 02/02/2017 |
| Recruitment end date | 28/02/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Woodland Road Surgery
Woodland Road
Northfield
Birmingham
B31 2HZ
United Kingdom
Northfield
Birmingham
B31 2HZ
United Kingdom
Maypole Health Centre
10 Sladepool Farm Road
Birmingham
B14 5DJ
United Kingdom
Birmingham
B14 5DJ
United Kingdom
Ash Tree Surgery
1536 Pershore Road
Stirchley
Birmingham
B30 2NW
United Kingdom
Stirchley
Birmingham
B30 2NW
United Kingdom
Kings Norton Surgery
66 Redditch Road
Birmingham
B38 8QS
United Kingdom
Birmingham
B38 8QS
United Kingdom
West Heath Medical Centre
West Heath Medical Centre
194-196 West Heath Road
Birmingham
B31 3HB
United Kingdom
194-196 West Heath Road
Birmingham
B31 3HB
United Kingdom
Riverbrook Medical Centre
3 River Brook Drive
Birmingham
B30 2SH
United Kingdom
Birmingham
B30 2SH
United Kingdom
The Wand Medical Centre
15 Frank Street
Highgate
Birmingham
B12 0UF
United Kingdom
Highgate
Birmingham
B12 0UF
United Kingdom
Sparkbrook Community and Health Centre
34 Grantham Road
Sparkbrook
Birmingham
B11 1LU
United Kingdom
Sparkbrook
Birmingham
B11 1LU
United Kingdom
St George's Surgery
119 School Road
Moseley
Birmingham
B13 9TX
United Kingdom
Moseley
Birmingham
B13 9TX
United Kingdom
Greet Medical Practice
50 Percy Road
Birmingham
B11 3ND
United Kingdom
Birmingham
B11 3ND
United Kingdom
Fernley Medical Centre
560 Stratford Road
Birmingham
B11 4AN
United Kingdom
Birmingham
B11 4AN
United Kingdom
The Balaji Surgery
2 Blackford Road
Sparkhill
Birmigham
B11 3SH
United Kingdom
Sparkhill
Birmigham
B11 3SH
United Kingdom
Bournville surgery
41B Sycamore Road
Birmingham
B30 2AA
United Kingdom
Birmingham
B30 2AA
United Kingdom
Sponsor information
NHS Birmingham South and Central CCG
Hospital/treatment centre
Hospital/treatment centre
Bartholomew House
142 Hagley Road
Birmingham
B16 9PA
England
United Kingdom
Funders
Funder type
Government
National Institute for Health Research
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned submission of a protocol paper to the Journal of Medical Internet Research. Further publications in high impact factor Digital Health and Oncology/Urology journals are planned for submission during 2018 following completion of the study in November 2017. |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Participant information sheet | version V1.3 | 23/08/2016 | 09/01/2017 | No | Yes |
| Results article | results | 28/07/2017 | Yes | No |
Additional files
- ISRCTN31380482_PIS_23Aug16_V1.3.docx
- Uploaded 09/01/2017
Editorial Notes
10/09/2020: Cancer Research UK lay results summary link added to Results (plain English).
31/07/2017: Publication reference added.
06/06/2017: Cancer Help UK link added to plain English summary field
